The Food and Drug Administration conducted an inspection of your acidified food manufacturing facility from May 21, 2008 to May 28, 2008. The inspection revealed that you manufacture several varieties of acidified food products at this facility.

As a manufacturer of acidified food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR Part 114). The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 114. In addition, based upon certain criteria in Part 114, acidified foods may be adulterated within the meaning of section 402(a)(3) of the Act (21 U.S.C. § 342(a)(3)) in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they otherwise unfit for food, or within the meaning of section 402(a)(4) (21 U.S.C. § 342(a)(4)) in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the Emergency Permit Control and Acidified Food regulations through links on the Food and Drug Administration (FDA) home page at http://www.fda.gov

Acidified foods are low-acid foods to which acid or acid foods are added. They have a water activity greater than 0.85 and a finished equilibrium pH of 4.6 or below (21 CFR 114.3(b)). Your "Hannah's Red" and "Hannah's Clear" pickled eggs are considered to be acidified foods because the predominant ingredient in each product is a low-acid ingredient (eggs) that is acidified by the addition of vinegar to the product. During the inspection, our investigator documented deviations from the Act and the above mentioned regulations related to the processing of your "Hannah's Red" and "Hannah's Clear" pickled eggs. These deviations cause these acidified food products to be adulterated under section 402(a)(4) of the Act.

Based on the inspection, the significant violations are as follows:

The products listed below were not manufactured in accordance with your scheduled processes, as required by 21 CFR Part 114.80(a)(1). Specifically, the scheduled processes specify that a (b)(4) ambient hold time is required prior to shipment. However, these products were shipped before this (b)(4) period expired. The data listed below is from a review conducted by our investigator that revealed (b)(4) instances in which your firm failed to follow the scheduled process by shipping product prior to the ambient hold time being achieved:

Amount/Product

Lot#

Date Shipped

Date Permitted to Ship

46 cs. Hannah's Clear 128 oz:

(b)(4)

5/7/08

5/9/08

47 cs. Hannah's Clear 128 oz.

(b)(4)

5/7/08

5/9/08

100 cs. Hannah's Red 64 oz.

(b)(4)

5/7/08

5/9/08

50 cs. Hannah's Red 32 oz.

(b)(4)

5/7/08

5/9/08

99 cs. Hannah's Red 128 oz.

(b)(4)

3/28/08

3/31/08

116 cs. Hannah's Red 128 oz.

(b)(4)

3/28/08

3/31/08

117 cs. Hannah's Red 128 oz.

(b)(4)

3/28/08

3/31/08

15 cs. Hannah's Red 128 oz.

(b)(4)

3/28/08

3/31/08

At the conclusion of the inspection, you were presented with form FDA-483 (Inspectional Observations form) listing these deviations from the regulations. You informed our investigator that you would take appropriate corrective action. To date, however, your firm has not taken action to correct these deficiencies.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Emergency Permit Control regulations (21 CFR. Part 108), the Acidified Food regulations (21 CFR Part 114) and the Good Manufacturing Practice regulations (21 CFR Part 110). You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure or injunction and/or the issuance of an order requiring a permit before delivery of introduction or introducing your acidified products into interstate commerce.

Please notify this office in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

Additionally, we have the following comment based on sanitation deficiencies noted during the inspection:

Your firm failed to use water that is of adequate sanitary quality on food and food-contact surfaces, as required by 21 CFR 110.37(a). The water used in your firm's egg wash was murky and was not self-draining. Further, it did not contain any residual chlorine, as stated in the firm's sanitation procedures.

Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov